MR 5300 and MR 7700 R11 MR Systems
K223442Philips Medical Systems Nederlands B.V. · cleared 2022-12-23 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.7)
“The proposed MR 5300 and MR 7700 R11 MR Systems are based on the principle that certain atomic nuclei present in the human body will emit a weak relaxation signal when placed in a strong magnetic field and excited by a radio signal at the precession frequency. The emitted relaxation signals are analyzed by the system and a computed image reconstruction is displayed on a video screen. In this 510(k) submission, Philips Medical Systems Nederland B.V. will be addressing the following minor software enhancements to the proposed MR 5300 and MR 7700 R11 MR Systems when compared to the legally marketed primary predicate, Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems R11 (K213583, 05/16/2022) and the secondary predicate devices Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition, and MR 7700 with distributed Multi Nuclei (K213516, 03/03/2022) and MR 5300 (K212673, 11/19/2021): 1. SmartSpeed AI”
source quote (p.6)
“1. SmartSpeed AI”
source quote (p.8)
“Guidance for Industry and FDA Staff – Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued October 2, 2014 – document number 1825)”
Validation studies (1)
Bench
sample size not stated
standards: IEC60601-1 Edition 3, IEC60601-1-2 Edition 4, IEC60601-1-6 Edition 3, IEC62366-1 Edition 1, IEC60601-1-8 Edition 2, IEC60601-2-33 Edition 3, IEC 62304 Edition 1, NEMA MS-1 2008, NEMA MS-4 2010, NEMA MS-8 2008, NEMA PS 3.1-PS 3.20, ISO 14971 Edition 2, Device specific guidance document, entitled “Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices” (issued November 18, 2016 – document number 340), Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005 – document number 337), Guidance for Industry and FDA Staff – Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued October 2, 2014 – document number 1825), Guidance for Industry and FDA Staff – Applying Human Factors and Usability Engineering to Medical Devices (issued February 3, 2016 - document number 1757), Guidance for Industry and FDA Staff – Use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process” (issued June 16, 2016 – document number 1811), Guidance for Industry and FDA Staff – Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices (issued July 11, 2016 – document number 1400057), Guidance for Industry and FDA Staff – Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices (issued September 6, 2017 – document number 1500015)
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- recall_reason_pattern
Software/algorithm-related recall in product code LNH (Philips North America, initiated 2026-04-14): "The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98779
- recall_reason_pattern
Software/algorithm-related recall in product code LNH (Philips North America, initiated 2025-12-03): "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS)." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98111
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).